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February 18, 2014
08:02 EDTEBIOEleven Biotherapeutics initiates Phase 3 clinical study with EBI-005
Eleven Biotherapeutics announced that patient randomization and dosing are underway in the company’s first pivotal Phase 3 clinical study of EBI-005 for the treatment of moderate to severe dry eye disease, the OASIS study. EBI-005, the Company’s most advanced product candidate generated using its AMP-Rx platform, is a novel, topically administered Interleukin-1 receptor blocker currently in development for the treatment of dry eye disease and allergic conjunctivitis. EBI-005 was designed to bind and block the IL-1 receptor to prevent transmission of biological signals responsible for many of the signs and symptoms of ocular surface diseases. This pivotal Phase 3 trial will include approximately 650 subjects in the U.S. Subjects will be randomized to receive EBI-005 or a vehicle-control. The co-primary endpoints of the study are change in corneal fluorescein staining score and improvement in pain and discomfort. The safety and tolerability of EBI-005 compared to vehicle-control will also be evaluated. This pivotal Phase 3 trial was designed based on the results observed in the company’s Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease. Based on estimates of patient enrollment, the company expects that top line data from this pivotal Phase 3 study will be available in early 2015.
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